Cipla receives 6 observations from USFDA for Goa facility
Drug Approval

Cipla receives 6 observations from USFDA for Goa facility

There are no data integrity (DI) observations.

  • By IPP Bureau | August 28, 2022

Further to United States Food and Drug Administration (USFDA) inspection at Cipla Ltd's Goa manufacturing facility in September 2019 and the warning letter received in February 2020, the Goa plant recently underwent a USFDA inspection from 16th - 26th August 2022.

On conclusion of the inspection, the company has now received 6 observations with some referencing to the observations made during the September 2019 inspection. There are no data integrity (DI) observations. The company will work closely with the USFDA and is committed to address these within the stipulated time.

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